Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Phosphorus containing other than solely as part of an...
Reexamination Certificate
2006-05-16
2006-05-16
Henley, III, Raymond J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Phosphorus containing other than solely as part of an...
Reexamination Certificate
active
07045511
ABSTRACT:
A pharmaceutical formulation is provided comprising fosinopril which is the prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. The formulation is characterized by comprising in the range of about 0.25 to about 5% glyceryl dibehenate which has been found to be a highly useful lubricant in the manufacture of tablets according to the present invention, enhancing the stability of fosinopril as compared to prior art formulations.
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Gu, L. et al., “Drug-excipient Incompatibility Studies of the Pipeptide Angiotensin-Converting Enzyme Inhibitor, Moexipril Hydrochloride: Dry Powder Vs. Wet Granulation,”Pharmaceutical Research, vol. 7, No. 4, pp. 379-383 (Apr. 1990).
Al-Omari, M. et al., “Effect of the Drug-Matrix on the Stability of Enalapril Maleate in Tablet Formulations,”Journal of Pharmaceutical and Biomedical Analysis, vol. 25, No. 5-6, pp. 893-902 (Jul. 2001).
Actavis Group HF.
Henley III Raymond J.
Wenderoth , Lind & Ponack, L.L.P.
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